Drug product<br />solutions

Drug product
solutions

We have developed proprietary continuous technologies for the manufacturing of pharmaceutical drug products, which are able to be integrated with our upstream continuous processes, as well as the appropriate in-line PATs.

Our DRUg product solution

Extrusion Molding Coating (EMC): Our proprietary Integrated Extrusion-Molding-Coating process produces pharmaceutical-grade coated tablets in a continuous fashion. The drug substance is conveyed from the upstream continuous dryer to the loss-in-weight feeder dedicated to the API, which is placed above the twin-screw extruder of the EMC unit and in front of the loss-in-weight feeder intended for the excipients. The excipients gravimetric feeder is continuously filled with a pre-blended mixture of different excipients suitable for the final drug product quality attributes and process. Then both feeders continuously deliver the API and excipients in the correct API/excipient ratio to reach the desired drug load.
The powders are gradually processed by the extruder, which mixes the materials and applies shear under high temperature and pressure. The resulting homogeneous extrudate flows through the transfer manifold, which is the integration point between the extruder unit and the core injection unit. The transfer manifold is equipped with two optical grade windows, each one with its own adaptor and port, where PAT probes are installed. Then the extruded material enters the core injection unit with a specific process control algorithm. The core injection unit accumulates the material shot and then injects it into the mold cavities. The cavities, designed per the tablet’s shape and size requirements, are cooled down with a cooling agent that allows hardening of the molten formulation into the desired tablet shape. After the tablets are cooled and hardened, they are ejected and collected.
The EMC machine is also equipped with additional injection units which allow the Continuous Manufacturing of coated tablets; in the case of coated tablets, the tablet cores are injected and coated simultaneously.
The process is highly versatile as it can be used for solid dosage forms with crystalline or amorphous APIs, low and high dosage strengths, as well as immediate-, modified- and controlled-release drug delivery systems, thanks to the availability of polymers with a wide variety of melting temperatures and solubility profiles.

Thin Film/Electrospinning: These innovative processes produce solid oral dosage forms directly from solutions of purified API. A solution is processed either through thin-film casting or electroprocessing to produce a thin layer of an API/excipient matrix. The film is subsequently engineered to form tablets of consistent physical dimensions (e.g., thickness, diameter, and mass). All steps are continuous and run in an integrated manner. Our team  has electrospun biological products and demonstrated no loss of structure/function. We believe electrospinning can provide an alternative to the time- and cost-inefficient lyophilization process.

 

Related Paper

All published articles that relate to this specific technology and solution.

Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study
Model predictive in vitro dissolution testing in pharmaceutical continuous manufacturing: An equivalence study
Extrusion-Molding-Coating process advantages for Continuous Manufacturing of oral solid dosage forms
Extrusion-Molding-Coating process advantages for Continuous Manufacturing of oral solid dosage forms
Feasibility studies of Continuous Manufacturing of Injection Molding Tablets via Extrusion-Molding-Coating (EMC).
Feasibility studies of Continuous Manufacturing of Injection Molding Tablets via Extrusion-Molding-Coating (EMC).
Design and Commercialization of an End-to-End Continuous Pharmaceutical Production Process: A Pilot Plant Case Study
Design and Commercialization of an End-to-End Continuous Pharmaceutical Production Process: A Pilot Plant Case Study
E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals
E-factor analysis of a pilot plant for end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals